(79 days)
The Cutera Family of CoolGlide Aesthetic Lasers is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.
755 nm:
The Family of CoolGlide Aesthetic Lasers is indicated for temporary and permanent hair reduction on all skin types (Fitzpatrick I-VI), including tanned skin. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The Family of CoolGlide Aesthetic Lasers is also indicated for:
- treatment of benign pigmented lesions
- treatment of wrinkles
- photocoagulation of dermatological vascular lesions, such as, but not limited to, port wine stains, hemangiomas and telangiectasias
1064 nm:
Dermatology:
The Family of CoolGlide Aesthetic Lasers is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasias, rosacea, venus lake, leg veins, and poikiloderma of civatte; and treatment of benign cutaneous lesions, such as, but not limited to, warts, scriae, and psoriasis. The lasers are also intended for the treatment of benign pigmented lessons, such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos), and plaques.
Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The CoolGlide lasers are also indicated for the treatment of wrinkles, such as, but not limited to, periocular and perioral wrinkles.
The CoolGlide lasers are indicated for temporary and permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime.
The CoolGlide lasers are also indicated for the treatment for pseudofolliculitis barbae (PFB).
The lasers are also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The lasers are also indicated for treatment of mild to moderate inflammatory acne vulgaris.
The CoolGlide lasers are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The intended use of the integral cooling system in the CoolGlide laser handpiece is to provide cooling of the skin prior to laser treatment; for the reduction of pain during laser treatment; to allow for the use of higher fluences for laser treatments, such as hair removal and vascular lesions; and to reduce the potential side effects of laser treatments.
Surgical Applications:
The lasers are indicated for the incision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neckl otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g., menorrhagia), and urology.
532 nm:
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening. blanching, flattening, reduction of lesion size).
Optional Pulsed Light Handpiece:
For the treatment of benign pigmented lesions.
The Cutera Family of CoolGlide Aesthetic Lasers comprises a variety of laser and non-laser light sources, including single wavelength (755 nm Alexandrite, 1064 nm Nd:YAG or 532 nm Nd:YAG), multiple wavelength, pulsed light, and laser/pulsed light combination models. The Family of CoolGlide Aesthetic Lasers treats a wide range of dermatologic conditions requiring selective photothermolysis of target chromophores. The Family of CoolGlide Aesthetic Lasers consists of a system console, permanently attached laser handpiece, footswitch, handpiece resting tree, and detachable pulsed light handpieces.
The provided text describes the 510(k) premarket notification for the "Family of CoolGlide Aesthetic Lasers". This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study for a de novo device.
Therefore, many of the requested items (acceptance criteria table, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not present in this type of submission.
Here's a breakdown of the information that can be extracted and why other parts are missing:
Information from the document:
- Device Name: Family of CoolGlide Aesthetic Lasers
- K Number: K153671
- Predicates:
- Mechanism of Action: Lasers and pulsed light (755 nm Alexandrite, 1064 nm Nd:YAG, 532 nm Nd:YAG, 500-1300 nm pulsed light) for various dermatological and surgical applications, utilizing selective photothermolysis.
- Specific Clinical Information:
- For hair reduction, "Permanent hair reduction is defined as long-term, stable reduction in hair counts observed at 6, 9, and 12 months after the end of a treatment regime." This is a definition for a clinical outcome, not an acceptance criterion in the context of device performance testing.
- Performance Data: The document explicitly states "Results of Clinical Study: None." Instead, performance data is primarily focused on non-clinical tests demonstrating safety and electrical compatibility, as well as software verification and validation.
- IEC 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety
- IEC 60601-1-2 Medical Electrical Equipment 1-2 General Requirements for basic safety and essential performance
- Software Verification and Validation Testing Report V0066 rC Excel HR- Production V&V 2.1.0
- Comparison of Technical Specifications: A detailed table (Table 5) compares the technical specifications of the new device with its predicate devices. This comparison serves as the primary "proof" of substantial equivalence, demonstrating that the device operates within similar parameters to already cleared devices.
Why requested information is not available:
This document is a 510(k) premarket notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This pathway generally does not require new clinical studies to establish the safety and effectiveness of the device if its technology and intended use are similar to existing devices. Instead, it relies on comparison to predicates and non-clinical performance data (e.g., electrical safety, software validation).
Therefore, the concept of "acceptance criteria" based on clinical performance metrics and a "study that proves the device meets the acceptance criteria" in the way one would describe for a de novo or PMA submission is not applicable here. The "acceptance criteria" implicitly revolve around demonstrating similar technical specifications and confirming safety standards (IEC standards, software V&V).
Answer based on the provided text:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: For this 510(k), the acceptance criteria are not explicitly stated in terms of clinical performance metrics. Instead, "acceptance" is based on demonstrating substantial equivalence to predicate devices and adherence to recognized electrical safety and software standards. The performance is assessed by comparison of technical specifications and demonstrating compliance with safety standards.
- Reported Device Performance:
- Clinical Performance: None explicitly reported as a standalone clinical study for this submission. The device's clinical performance is implicitly considered equivalent to its predicates due to similar technology and indications for use.
- Technical Specifications (New Submission vs. Predicates - K132185 used as primary comparison):
| Feature | New Submission | Family of CoolGlide Aesthetic Lasers (K132185) |
|---|---|---|
| Wavelength(s) | 755 nm Alexandrite, 1064 nm Nd:YAG, 532 nm Nd:YAG, 500-1300 nm pulsed light | 755 nm Alexandrite, 1064 nm Nd:YAG, 532 nm Nd:YAG, 500–1300 nm pulsed light |
| Spot Size (755 nm) | 5–18 mm | 5, 8, 10, 12, 15, and 18 mm |
| Spot Size (1064 nm) | 3–18 mm | 3, 5, 8, 10, and 12 mm |
| Spot Size (532 nm) | 2–12 mm | 2–12 mm |
| Spot Size (500-1300 nm) | 30 x 10 mm | 30 x 10 mm |
| Output Mode | Pulsed | Pulsed |
| Repetition Rate (755 nm) | ≤2 Hz and single shot | ≤2 Hz and single shot |
| Repetition Rate (1064 nm) | ≤10 Hz and single shot | ≤10 Hz and single shot |
| Repetition Rate (532 nm) | ≤4 Hz and single shot | ≤4 Hz and single shot |
| Repetition Rate (500-1300 nm) | ≤1 Hz and single shot | ≤1 Hz and single shot |
| Laser Media | Flashlamp-pumped solid state rod | Flashlamp-pumped solid state rod |
| User Interface | Push button control or LCD color touchscreen | Push button control or LCD color touchscreen |
| Aiming Beam (755 nm) | 630-680 nm | 630-680 nm |
| Aiming Beam (1064 nm) | 630-680 nm | 630-680 nm |
| Aiming Beam (532 nm) | 630-680 nm | 630-680 nm |
| Aiming Beam (500-1300 nm) | none | none |
| Delivery Devices | Non-sterile, reusable, cleanable | Non-sterile, reusable, cleanable |
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Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is presented in this 510(k) submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert ground truth is presented.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a laser device, not an AI diagnostic tool, and no clinical study of this nature was conducted or reported for this 510(k).
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a laser device, not an AI algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of clinical performance ground truth for a new study. The ground truth for device safety and electrical performance is compliance with recognized standards.
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The sample size for the training set: Not applicable. Training sets are relevant for AI/ML algorithms, which this device is not.
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How the ground truth for the training set was established: Not applicable.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.